Product Support Engineer

ABOUT ORGANOX:

OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Field Service Engineer to join our team.

Position Summary

The Product Support Engineer will be primarily responsible for the on-site service and repair of complex electro-mechanical medical devices designed for organ preservation placed within United States region.   Reporting to the National Director of Field Engineering, the postholder will be responsible for providing technical support for OrganOx metra® retained units placed in United States to ensure that product reliability, quality and availability are maintained.  The Product Support Engineer will be responsible for completing all documentation relevant to installation, service, repair and rework in compliance with FDA “Good Documentation Practice” and “Good Manufacturing Practice”.  

Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete additional tasks reasonably requested by the National Director of Field Engineering. 

Major Responsibilities

Under direction from the National Director of Field Engineering, the Product Support Engineer will be responsible for:

·       Organizing and providing on-site service and repair of the OrganOx metra® device:

·       Travelling to hospitals and research facilities within United States.

·       Carrying out on-site routine maintenance procedures and liaising directly with customers regarding organizing routine services and other maintenance needs of OrganOx devices.

·       Carrying out on-site or back-to-base troubleshooting and re-work of OrganOx devices.

·       Carrying out Installation Testing, Post-Rework Soak and Acceptance Testing and completing all documentation in compliance with Good Documentation Practice and the OrganOx Quality Management System.

·       Ensuring work orders and service visits are completed within set time frames.

·       Assisting with major back-to-base repairs or device upgrades in OrganOx USA workshop, when necessary.

·       Short-term covering for the urgent technical needs of devices placed outside United States when the engineer assigned for that region is not available.

·       Working with the Product Support Engineering staff to maintain a stock of spare parts and consumables necessary for the technical support of the devices within United States.

·       Managing a local spare part stock in a local facility and trunk stock within United States under the guidance of the National Director of Field Engineering.

·       Managing and maintenance, including recalibration, of various test equipment, battery calibrators, tools and accessories required during providing technical service within United States.

·       Adhering to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

·       Completing technical reports to a high standard.

·       To assist the National Director of Field Engineeringin maintaining the technical documentation and device history records.

·       Ensure that vendor credentialing requirements are current

Requirements

Skills and Experience

The Product Support Engineer will have:

·         Three years or more industry experience servicing and repairing Medical Devices or other complex critical devices.

·         A strong and broad working knowledge of electrical and mechanical engineering systems.

·         A good track record of demonstrating analytical problem-solving skills.

·         Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team.

·         Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English.

·         Freedom to travel within United States to carry out servicing, repairs, trouble shooting, and other device maintenance activities as required.

·         Commitment to travel with short notice and to stay away from home for several consecutive days at a time. Travel and onsite servicing will average 80% of working time; this could potentially increase to 90% of working time during specific peaks of activity (such as dep